Genentech’s phase III studies of ocrelizumab in people with relapsing multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS) show positive results
Study shows that ocrelizumab was superior to interferon beta-1a (Rebif) in reducing the three major markers of disease activity
Data from two identical studies in people with relapsing MS showed ocrelizumab was superior to interferon beta-1a (Rebif) in reducing the three major markers of disease activity over the two-year controlled treatment period.
In a separate study in people with PPMS, ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo.
Additionally, the study met other secondary endpoints of reducing the time required to walk 25 feet, the volume of chronic inflammatory brain lesions and brain volume loss.
Sandra Horning, chief medical officer and head of global product development, said: “The results of these trials have the potential to transform the treatment of MS.
“Ocrelizumab is the first investigational medicine to significantly reduce disability progression in people with relapsing MS and people with primary progressive MS. We are eager to work with regulatory authorities to bring this investigational medicine to the MS community as soon as possible.”
Xavier Montalban, professor of neurology and neuroimmunology at Vall d’Hebron University Hospital and Research Institute, Barcelona, said: “This is an important moment for the MS community. For decades, trial after trial has failed to show the benefit of any medicine for people with primary progressive MS.
“Now, for the first time, we have a positive phase III study result for people with this debilitating form of the disease.”
Genentech plans to pursue marketing authorisation for ocrelizumab in relapsing MS and in PPMS.
Data from the ocrelizumab study will be submitted to the US Food and Drug Administration in early 2016.